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The UK subsidiary of Dutch drugmaker argenx confirmed today that its investigational therapy, subcutaneous efgartigimod alfa has been granted Promising Innovative Medicine (PIM) designation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). 28 November 2024
Pharmaceutical
The first iteration of the European Shortages Monitoring Platform (ESMP) has gone live. 28 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, a novel, central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI), for the treatment of classic galactosemia, under development by Applied Therapeutics. 28 November 2024
Biotechnology
The US Food and Drug Administration has received new reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), following treatment of early, active cerebral adrenoleukodystrophy (CALD) patients with Skysona (elivaldogene autotemcel). 28 November 2024
Generics
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 28 November 2024
Pharmaceutical
UK-based drugmaker Advanz Pharma has announced that following the grant of a temporary suspension, as announced on last month, the General Court of the European Union (General Court) has decided not to further extend the suspension of the European Commission (EC) decision to revoke the conditional marketing authorization (CMA) for Ocaliva (obeticholic acid) in Europe. 28 November 2024
Biotechnology
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeOne Medicines, formerly BeiGene. 27 November 2024
Biotechnology
After trading closed yesterday, Exelixis revealed that the US Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. 27 November 2024
Pharmaceutical
The European Commission (EC) has approved a single-vial, fully liquid presentation of Menveo (meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W and Y, UK pharma major GSK announced today. 27 November 2024
Pharmaceutical
Novartis announced today that the European Commission (EC) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence. 27 November 2024
Biotechnology
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
Pharmaceutical
The Biden administration has proposed a new rule that could significantly expand Medicare and Medicaid coverage for obesity medications, potentially benefiting millions of Americans. 27 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has extended the review period for Soleno Therapeutics’ the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets 27 November 2024
Pharmaceutical
Japanese drugmaker Otsuka has announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare (MHLW) for the manufacture and sale in Japan of bempedoic acid - trade name Nexletol in Japan - for the treatment of hypercholesterolemia and familial hypercholesterolemia. 27 November 2024
Pharmaceutical
Berlin, Germany-based Eckert & Ziegler Radiopharma has received approval of its proprietary non-carrier added Lutetium-177 chloride, Theralugand, by the European Commission (EC). 27 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy. 25 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers, from privately-held US-Ireland-based pharmaceutical company Shorla Oncology. 25 November 2024
Biotechnology
StemCyte, a subsidiary of StemCyte International, has secured approval from the US Food and Drug Administration for Regenecyte, a cord blood-derived stem cell therapy. 25 November 2024
Pharmaceutical
In what could be construed to be India's quest for pharmaceutical supremacy, a clarion call has been made for the country to set its indigenous standards. 25 November 2024
Pharmaceutical
Lexicon Pharmaceuticals has announced a major strategic shift, prioritizing its late-stage pipeline following a rejection by the US Food and Drug Administration (FDA). 25 November 2024
Pharmaceutical
Stronger warnings are needed on drugs that can cause patients to lose control of their behavior, leading to pathological gambling, hypersexuality, and compulsive shopping or eating, Public Citizen said in a petition to the US Food and Drug Administration. 29 June 2016
article
US pharma company AbbVie said today that the US Food and Drug Administration has granted a fourth Breakthrough Therapy designation (BTD) for Imbruvica (ibrutinib) as a potential treatment of chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy. 29 June 2016
Biotechnology
The US Food and Drug Administration has placed a clinical hold on studies of the Regulus Therapeutics drug RG-101 for the treatment of chronic hepatitis C virus (HCV). 29 June 2016
Pharmaceutical
A US Food and Drug Administration advisory committee yesterday voted 12-11 that substantial evidence exists to establish that Jardiance (empagliflozin) reduces cardiovascular (CV) death in adults with type 2 diabetes (T2D) and established CV disease. 29 June 2016
Pharmaceutical
A group of four pharma industry associations have signed a memorandum of understanding in China to adopt pro-medicine and patient-centered principles, build public consensus on the value of medical representatives and establish a national system to manage them, and promote proper and orderly development of the sector. 29 June 2016
Biotechnology
There was good news today for US biotech giant Gilead Sciences, when the US Food and Drug Administration gave its approval for the company’s Epclusa (sofosbuvir/velpatasvir), the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. 28 June 2016
Pharmaceutical
New Zealand’s Pharmaceutical Management Agency PHARMAC has announced a decision to fund nivolumab (trade name Opdivo), from US pharma major Bristol-Myers Squibb, for patients with unresectable or metastatic (stage III or IV) melanoma (advanced melanoma) from July 1, 2016. 28 June 2016
Biotechnology
The marketing application submitted by Swiss pharma giant Roche or Ocrevus (ocrelizumab) to treat two forms of multiple sclerosis has been accepted for review by both the European and US regulators. 28 June 2016
Biotechnology
The European Medicines Agency has granted marketing approval to the mylife YpsoPump for use with the prefilled pump cartridge NovoRapid PumpCart. 28 June 2016
Pharmaceutical
The European Commission has granted marketing authorization for Zavicefta (ceftazidime-avibactam, previously known as CAZ AVI), a new combination antibiotic for the treatment of patients with serious Gram-negative bacterial infections requiring hospitalization. 28 June 2016
Biotechnology
USA-based Puma Biotechnology said today that it has submitted its Marketing Authorization Application to the European Medicines Agency for neratinib. 27 June 2016
Biotechnology
USA-based Cytori Therapeutics today announced that the use of Cytori Cell Therapy was approved for clinical use on June 24, to treat knee osteoarthritis. 27 June 2016
Biotechnology
Swedish Orphan Biovitrum has announced that it has received approval in Switzerland for the use of hemophilia A treatment Elocta (rFVIIIFc), which it is co-developing with US biotech major Biogen. 27 June 2016
Pharmaceutical
While the exit of the UK from the European Union undoubtedly creates significant issues for the UK pharmaceutical and medical device industries in ensuring highly regulated European markets remain open to business, opportunities remain for these sectors to thrive. 27 June 2016
Pharmaceutical
Britain's unexpected vote on Thursday to leave the European Union, which saw currency and stock markets in turmoil in Friday, has left many scrambling to determine the impact on markets and various sectors. 26 June 2016
Generics
At its June meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of six new medicines, including one advanced therapy medicinal product (ATMP). 25 June 2016
Pharmaceutical
USA-based drug manufacturer and contract development firm Pharmaceutics International is now the subject of a European Medicines Agency review into alleged failures to adhere to good manufacturing practice (GMP) at its UK site. 24 June 2016
Pharmaceutical
As reported earlier today, the UK has voted to leave the European Union, with the news sending sterling and stocks into turmoil, as well as the resignation of Prime Minister David Cameron. 24 June 2016
Pharmaceutical
The UK subsidiary of Japanese drug major Astellas Pharma has been suspended as a member of the Association of the British Pharmaceutical Industry (ABPI) with effect from June 24, 2016. 24 June 2016
Pharmaceutical
The Indian government has withdrawn a Bill introduced in 2013 to amend the existing Drugs and Cosmetics Act, promising to ‘comprehensively review’ regulations to suit new science and research methods. 23 June 2016
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